Ignite Creation Date:
2024-05-06 @ 11:06 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03434600
Status:
COMPLETED
Last Update Posted:
2019-05-20
First Post:
2018-02-09
Brief Title:
Comparison of Oxford UKA and Sigma UKA With RSA
Sponsor:
Regional Hospital Holstebro
Organization:
Regional Hospital Holstebro
Study Overview
Official Title:
Comparison of the Oxford Unicompartmental Knee Prosthesis With the Sigma High Performance Partial Knee Using Rontgen Stereophotogrammetric Analysis in Patients With Primary Medial Unicompartmental Knee Osteoarthritis
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Comparison of two unicompartmental knee arthroplasties UKA to see if Sigma UKA performs equally good as the Oxford UKA The study focuses on how well the arthroplasty is fixated to the bone and on the difference in wear of the plastic insert Finally the functional outcome after surgery is compared between the two arthroplasties
Hypothesis
H1 The Sigma UKA has an equal migration pattern compared to the Oxford UKA with a follow up of two years - that is no significant difference in migration between 1-2 years follow-up
H2 The Oxford and Sigma UKAs have comparable polyethylene wear with a follow up of 5 years
H3 The Oxford and Sigma UKAs have comparable patient perceived outcome measures PROM and leg extension power LEP postoperative
H4 BMD of the proximal tibia does not influence migration of the tibial component
Hypothesis
H1 The Sigma UKA has an equal migration pattern compared to the Oxford UKA with a follow up of two years - that is no significant difference in migration between 1-2 years follow-up
H2 The Oxford and Sigma UKAs have comparable polyethylene wear with a follow up of 5 years
H3 The Oxford and Sigma UKAs have comparable patient perceived outcome measures PROM and leg extension power LEP postoperative
H4 BMD of the proximal tibia does not influence migration of the tibial component
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None